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AzTrials

Crohn's DiseasePhase 2NCT03395184

Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease

A Phase 2 study testing PF-06651600 and PF-06700841 in people with Crohn's Disease, run by Pfizer at 195 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn's Disease
What is being tested?
PF-06651600 and PF-06700841
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
244 participants
Where
195 sitesin 26 countries
Study dates
2 Feb 2018to 19 Oct 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and/or female subjects 18 years to 75 years of age
  • Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.
  • Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.
  • An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.
  • Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:
  • •Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).
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  • Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below:
  • Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.
  • Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.
  • Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.

Who cannot join

  • Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.
  • Presence of active (draining) fistulae or intra abdominal or perineal abscesses.
  • Strictures with obstructive symptoms.
  • Short bowel syndrome.
  • History of bowel perforation requiring surgical intervention within the past 12 months.
  • Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.
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  • History of bowel surgery within 6 months prior to baseline.
  • Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
  • Subjects with primary sclerosing cholangitis.
  • Subjects with evidence of colonic adenomas, dysplasia or neoplasia.
  • Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.
  • Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.
  • Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period:
  • >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.
  • IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.
  • Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.
  • Anti TNF inhibitors (or biosimilars thereof) as described below:
  • Infliximab within 8 weeks prior to baseline;
  • Adalimumab within 8 weeks prior to baseline;
  • Certolizumab within 8 weeks prior to baseline;
  • Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.
  • Ustekinumab within 8 weeks prior to baseline.
  • Interferon therapy within 8 weeks prior to baseline.
  • Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).
  • Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.
  • Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.
  • Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.
  • Subjects who have received other JAK inhibitors within 3 months prior to baseline.
  • Subjects who have not responded to or have been intolerant of other JAK inhibitors.
  • Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.
  • 14) Subjects with history of thrombotic event(s), including deep venous thrombosis (DVT), and known inherited conditions that predispose to hypercoagulability.

Trial locations and contacts

195 sites in 26 countries.

195 sites in 26 countries

United States57 sites

  • First Street Hospital

    Bellaire, Texas, 77401

  • First Street Surgical Center

    Bellaire, Texas, 77401

  • Brighton Surgical Center

    Beverly Hills, California, 90210

  • Treasure Valley Medical Research

    Boise, Idaho, 83706

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Mass Eye and Ear, Longwood

    Boston, Massachusetts, 02115

  • UNC Hospitals

    Chapel Hill, North Carolina, 27514

  • UNC Hospitals Endoscopy Center at Meadowmont

    Chapel Hill, North Carolina, 27517

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Brigham and Women's Hospital

    Chestnut Hill, Massachusetts, 02467

  • Chevy Chase Endoscopy Center

    Chevy Chase, Maryland, 20815

  • MGG Group Co., Inc., Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Gastro Florida

    Clearwater, Florida, 33756-3839

  • Gastro Florida

    Clearwater, Florida, 33756

  • West Coast Endoscopy Center

    Clearwater, Florida, 33756

  • Gastro Florida

    Clearwater, Florida, 33762

  • Front Range Endoscopy Center

    Colorado Springs, Colorado, 80903

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

  • Dothan Surgery Center

    Dothan, Alabama, 36301

  • Gut P.C., dba Digestive Health Specialists of the Southeast

    Dothan, Alabama, 36305

  • Gastroenterology Associates of Northern VA

    Fairfax, Virginia, 22031

  • Gastroenterology Associates of Northern Virginia

    Fairfax, Virginia, 22031

  • Verity Research, Inc.

    Fairfax, Virginia, 22031

  • UNC GI Procedures Hillsborough

    Hillsborough, North Carolina, 27278

  • Hermann Drive Surgical Hospital

    Houston, Texas, 77004

  • Pearland Surgery Center

    Houston, Texas, 77047

  • UF Health Jacksonville - Gastroenterology Emerson

    Jacksonville, Florida, 32207

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Holston Valley Surgery Center

    Kingsport, Tennessee, 37660

  • Entertainment Medical Group

    Los Angeles, California, 90036

  • Gastrointestinal Biosciences Clinical Trials, LLC

    Los Angeles, California, 90067

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

  • Eastside Endoscopy Center

    Macomb, Michigan, 48044

  • Vanderbilt GI Endoscopy Lab at One Hundred Oaks

    Nashville, Tennessee, 37204

  • Vanderbilt Inflammatory Bowel Disease Clinic

    Nashville, Tennessee, 37204

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212-1375

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212-1610

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-5543

  • Vanderbilt Inflammatory Bowel Disease Clinic

    Nashville, Tennessee, 37232

  • Weill Cornell Medical College - New York Presbyterian Hospital

    New York, New York, 10021

  • Weill Cornell Medical College

    New York, New York, 10021

  • New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)

    New York, New York, 10065

  • New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy

    New York, New York, 10065

  • Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)

    New York, New York, 10065

  • Weill Cornell Medical College - New York Presbyterian Hospital

    New York, New York, 10065

  • DiGiovanna Institute for Medical Education And Research

    North Massapequa, New York, 11758-1853

  • Millenia Surgery Center

    Orlando, Florida, 32811

  • HMD Research LLC

    Orlando, Florida, 32819

  • Stanford Medicine Outpatient Center - Digestive Health Center

    Redwood City, California, 94063

  • Capitol Research

    Rockville, Maryland, 20850

  • WestGlen Gastrointestinal Consultants, P.A.

    Shawnee Mission, Kansas, 66217

  • GI Alliance

    Southlake, Texas, 76092

  • Lonestar Endoscopy, LLP

    Southlake, Texas, 76092

  • Texas Digestive Disease Consultants (Administrative, Regulatory)

    Southlake, Texas, 76092

  • Gastroenterology Associates of the Piedmont, PA

    Winston-Salem, North Carolina, 27103

  • PMG Research of Winston-Salem, LLC

    Winston-Salem, North Carolina, 27103

Other trials in United States

Poland36 sites

  • Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus

    Katowice, 40-659

  • ETG Kielce

    Kielce, 25-355

  • Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla

    Knurów, 44-190

  • Szpital w Knurowie Sp. z o.o.

    Knurów, 44-190

  • Samodzielny Publiczny Zespół Opieki Zdrowotnej, Pracownia Endoskopii

    Kościan, 64-000

  • Centrum Medyczne Szpital Swietej Rodziny Sp z o.o.

    Lodz, 90-302

  • Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp z o.o.

    Lodz, 90-302

  • Ośrodek Badań Klinicznych Appletreeclinics

    Lodz, 90-349

  • SALVE

    Lodz, 92-551

  • Gastromed Sp. z o.o.

    Lublin, 20-582

  • IRMED

    Piotrkow Trybunalski, 97-300

  • Samodzielny Szpital Wojewodzki im. M. Kopernika w Piotrkowie Trybunalskim

    Piotrkow Tryunalski, 91-300

  • PRZYCHODNIA SPECJALISTYCZNA MEDIC-R Clinical Research Center Spolka z ograniczona odpowiedzialnoscia

    Poznan, 60-848

  • Ai Centrum Medyczne Sp. Z O.O. Sp.K.

    Poznan, 61-113

  • AM-MEDIC SP. z o.o.

    Poznan, 61-315

  • Gabinety Lekarskie Rivermed

    Poznan, 61-441

  • PRZYCHODNIA SPECJALISTYCZNA MEDIC-R Clinical Research Center Spolka z ograniczona odpowiedzialnoscia

    Poznan, 61-731

  • KO-MED Centra Kliniczne

    Puławy, 24-100

  • Zaklad Opieki Zdrowotnej Medical Sp. z o.o., (endoscopy)

    Puławy, 24-110

  • ENDOSKOPIA Sp. z o. o.

    Sopot, 81-756

  • Szpital Sredzki Serca Jezusowego sp. z o.o.

    Środa Wielkopolska, 63-000

  • Nowe Zdrowie-CK, Kiełtucki i Wspólnicy Sp.j.

    Staszów, 28-200

  • STRZEGOMSKIE CENTRUM MEDYCZNO-DIAGNOSTYCZNE Sp. z o.o.

    Strzegom, Lower Silesian Voivodeship, 58-150

  • DC-MED Sp. z o.o. Sp.k.

    Swidnica, Other, 58-100

  • Twoja Przychodnia Szczecinskie Centrum Medyczne

    Szczecin, 71-434

  • SONOMED

    Szczecin, 71-685

  • H-T. Centrum Medyczne-Endoterapia

    Tychy, Silesian Voivodeship, 43-100

  • Centrum Zdrowia MDM

    Warsaw, 00-635

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728

  • Endoterapia PFG Sp. z o.o.

    Warsaw, 02-653

  • Centrum Diagnostyczno-Lecznicze Barska Sp. z o. o.

    Włocławek, 87-800

  • Futuremeds

    Wroclaw, 50-088

  • Melita Medical Sp. z o.o.

    Wroclaw, 50-449

  • Centrum Gastrologiczno Hepatologiczne

    Wroclaw, 50-555

  • Lexmedica

    Wroclaw, 53-114

  • Golden Care

    Wroclaw, 54-130

Other trials in Poland

Russia20 sites

  • LLC "Alliance Biomedical-Ural Group"

    Izhevsk, Udmurt Republic, 426061

  • LLC "Alliance Biomedical-Ural Group"

    Izhevsk, 426061

  • LLC "Olla-Med"

    Moscow, 105554

  • Sechenov University on the base of Institute of Translational Medicine and Biotechnology

    Moscow, 119435

  • Limited Liability Company "Medical Center SibNovoMed"

    Novosibirsk, 630005

  • Novosibirskiy Gastrocenter

    Novosibirsk, 630007

  • Clinic at FSBEI HE "Omsk State Medical University" MoH RF

    Omsk, 644050

  • Private Medical Institution "Euromedservice"

    Pushkin, Sankt-Peterburg, 196603

  • Polyclinic Ultrasound 4D LLC

    Pyatigorsk, Stavropol Kray, 357502

  • LLC "New Clinic"

    Pyatigorsk, 357500

  • SPb SBIH "City Hospital #40 of the Kurortnyi region"

    Saint Petersburg, Sestroretsk, 197706

  • Limited Liability Company "Medical Center "Reavita Med SPb" (OOO "MC "RM SPb")

    Saint Petersburg, 194354

  • Limited Liability Company "RIAT"

    Saint Petersburg, 195220

  • LLC "Research center Eco-Safety"

    Saint Petersburg, 196143

  • Limited Liability Company "RIAT SPb"

    Saint Petersburg, 197343

  • Saint-Petersburg State Budgetary Healthcare Institution "City Clinical Hospital of the Righteous

    Saint Petersburg, 197706

  • Private Institution Educational Organization of Higher Education

    Samara, 443011

  • Non-state Healthcare Institution 'Railway Clinical Hospital at Samara Station of Open Joint Stock

    Samara, 443029

  • Limited Liability Company Medical Company "Hepatolog"

    Samara, 443093

  • State Budgetary Healthcare Institution of the Stavropol Region

    Stavropol, 355017

Other trials in Russia

Ukraine13 sites

  • Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital", Surgery Department

    Chernivtsi, 58001

  • Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 n.a. prof. O.O. Shalimov

    Kharkiv, 61037

  • Medical Centre Medical Clinic Blagomed LLC

    Kyiv, 01023

  • Medical Center "OK Clinic+" of International Institute of Clinical Trials

    Kyiv, 02091

  • Medical Center "Universal clinic Oberig" of "Kapital" LLC, Gastro center

    Kyiv, 03680

  • Municipal Non-profit enterprise of Kyiv Regional Council "Kyiv regional hospital"

    Kyiv, 04078

  • Municipal non-profit enterprise of Kyiv regional council "Kyiv regional clinical hospital"

    Kyiv, 04107

  • Lviv clinical hospital on Railway Transport of Health Care Center branch of PJSC Ukrainian Railway

    Lviv, 79007

  • Vinnytsia City Clinical Hospital No.1

    Vinnytsia, 21000

  • Private Small-Scale Enterprise Medical Center "Pulse"

    Vinnytsia, 21001

  • Vinnytsia Regional Clinical Hospital for War Veterans

    Vinnytsia, 21005

  • Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov

    Vinnytsia, 21018

  • Medical Center "DIACENTER"LLC

    Zaporizhzhya, 69076

Other trials in Ukraine

Italy8 sites

  • A.O.Spedali Civili

    Brescia, BS, 25123

  • IRCCS Saverio de Bellis

    Castellana Grotte, BARI, 70013

  • Univ. "Magna Graecia" di Catanzaro

    Catanzaro, CZ, 88100

  • A.O.U. Policlinico G. Martino

    Messina, 98125

  • ASST Monza

    Monza, MB, 20090

  • Azienda Ospedaliera di Padova

    Padova, 35128

  • Policlinico Universitario Campus Bio-Medico

    Roma, 00128

  • Istituto Clinico Humanitas IRCCS - Sez. Autonoma di Malattie, Infiammatorie Croniche Intestinali

    Rozzano, Milan, 20089

Other trials in Italy

Czechia6 sites

  • Nemocnice Horovice, a.s.

    Hořovice, 268 31

  • Hepato-Gastroenterologie HK s.r.o.

    Hradec Králové, 500 12

  • Medialpharma s.r.o.

    Hradec Králové, 500 12

  • MUDr. GREGAR s.r.o.

    Olomouc, 77900

  • Nemocnice Strakonice, a.s., Interni oddeleni

    Strakonice, 386 01

  • Nemocnice Strakonice, a.s.

    Strakonice, 386 29

Other trials in Czechia

Serbia5 sites

  • KBC "Dr Dragisa Misovic-Dedinje"

    Belgrade, 11040

  • Klinicki Centar Kragujevac

    Kragujevac, Srbija, 34000

  • Opsta bolnica Subotica

    Subotica, Srbija, 24000

  • Klinicko Bolnicki Centar "Bezanijska Kosa"

    Zemun, Beograd, 11080

  • Opsta Bolnica "Djordje Joanovic", Odeljenje Interno, Odsek Gastroenterologija

    Zrenjanin, Srbija, 23000

Other trials in Serbia

Spain5 sites

  • Hospital Universitario Fundacion Alcorcon

    Alcorcón, Madrid, 28922

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Turkey (Türkiye)5 sites

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 06230

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli, 41380

  • Mersin Universitesi Tip Fakultesi Hastanesi, Ic Hastaliklari

    Mersin, 33110

  • Mersin Universitesi Tip Fakultesi Hastanesi

    Mersin, 33110

  • Bulent Ecevit Universitesi Tip Fakultesi

    Zonguldak, 67600

Other trials in Turkey (Türkiye)

Australia4 sites

  • Ballarat Base Hospital

    Ballarat, Victoria, 3350

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Mater Misericordiae Ltd

    South Brisbane, Queensland, 4101

  • Saint John of God Health Care Inc.

    Subiaco, Western Australia, 6008

Other trials in Australia

Hungary4 sites

  • Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz

    Békéscsaba, 5600

  • Semmelweis Egyetem, II. Belgyogyaszati Klinika

    Budapest, 1088

  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

    Budapest, 1125

  • Clinfan Szolgaltato Kft.

    Szekszárd, 7100

Other trials in Hungary

Lebanon4 sites

  • American University of Beirut Medical Center

    Beirut

  • Saint George Hospital University Medical Center

    El Achrafiyé

  • Ain Wazein Medical Village

    El Chouf

  • Hammoud Hospital University Medical Center

    Saida

Other trials in Lebanon

Belgium3 sites

  • University Hospital Brussels

    Jette, 1090

  • University Hospitals Leuven

    Leuven, 3000

  • CHC MontLégia

    Liége, 4000

Other trials in Belgium

Croatia3 sites

  • Klinicki Bolnicki centar Split, Zavod za gastroenterologiju

    Split, 21000

  • Klinicka bolnica Dubrava Zagreb

    Zagreb, 10000

  • Klinicki bolnicki centar Zagreb, Zavod za gastroenterologiju i hepatologiju

    Zagreb, 10000

Other trials in Croatia

Georgia3 sites

  • LTD "Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine"

    Tbilisi, 0112

  • The First University Clinic of TSMU

    Tbilisi, 0141

  • Institute of Clinical Cardiology, Ltd.

    Tbilisi, 0159

Other trials in Georgia

Germany3 sites

  • Paian MED Research GmbH

    Berlin, 10318

  • Krankenhaus Waldfriede e.V.,

    Berlin, 14163

  • Universitaetsklinikum Schleswig-Holstein

    Kiel, 24105

Other trials in Germany

South Korea3 sites

  • Kyungpook National University Hospital

    Daegu, Korea, 41944

  • Kyung Hee University Hospital

    Seoul, 02447

  • Kangbuk Samsung Hospital

    Seoul, 03181

Other trials in South Korea

Saudi Arabia2 sites

  • King AbdulAziz Medical City

    Riyadh, 11426

  • King Khalid University Hospital

    Riyadh, 11472

Other trials in Saudi Arabia

Slovakia2 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica

    Banská Bystrica, 975 17

  • ENDOMED, s.r.o.

    Vranov nad Topľou, 093 01

Other trials in Slovakia

South Africa2 sites

  • Dr Wright Private Practice

    Claremont, Western Cape, 7708

  • Wits Clinical Research Trial Site

    Parktown, Gauteng, 2193

Other trials in South Africa

Tunisia2 sites

  • La Rabta Hospital

    Tunis, 1007

  • Habib Thameur Hospital

    Tunis, 1008

Other trials in Tunisia

Austria1 site

  • AKH Wien Universitaetsklinik fuer Innere Medizin III

    Vienna, 1090

Other trials in Austria

Bosnia and Herzegovina1 site

  • Javna zdravstvena ustanova Univerzitetski klinicki centar Republike Srpske,

    Banja Luka, 78000

Other trials in Bosnia and Herzegovina

Canada1 site

  • Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Switzerland1 site

  • Universitätsspital Zürich

    Zurich, CH-8091

Other trials in Switzerland

United Arab Emirates1 site

  • Emirates Specialty Hospital

    Dubai, PO BOX 505240

Other trials in United Arab Emirates

About this study

Official title: A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE

The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.

Conditions
Crohn's Disease
Being tested
PF-06651600 Placebo, PF-06651600, Placebo PF-06700841, PF-06700841
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-06651600 PlaceboDrug

    12 weeks, followed by PF-06651600, 50 mg once daily (QD) for 52 weeks

  • PF-06651600Drug

    200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks

  • Placebo PF-06700841Drug

    12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks

  • PF-06700841Drug

    60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks

Study groups in NCT03395184
Study groupRoleWhat they receive
PF-06700841 or placeboExperimentalNot described
Receives: Drug: Placebo PF-06700841; Drug: PF-06700841
PF-06651600 or placeboExperimentalNot described
Receives: Drug: PF-06651600 Placebo; Drug: PF-06651600

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction in Simple Endoscopic Score for Crohn's Disease (SES CD50) at Week 12: Induction Period

    SES CD50 was defined as 50% improvement from baseline in SES-CD. Baseline was defined as last measurement prior to first dosing on Day 1. Following bowel segments were used for calculating SES-CD scores: Ileum, right colon(C), transverse C, left C and rectum. Each segment assessed for four domains: presence of ulcers, ulcerated surface, affected surface and presence of narrowing, each scored on a scale of 0 to 3, higher scores indicated more severe condition. Presence of ulcers score: 0=none, 1=small ulcer: (0.1-0.5 centimeter[cm]), 2=Large ulcer(0.5-2 cm), 3=very large ulcer(>2 cm); ulcerated surface score: 0=none, 1=<10%, 2=10-30% and 3=>30%; affected surface score: 0=unaffected segment, 1=<50%, 2=50-75% and 3=>75%; presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed and 3=cannot be passed. Total SES CD score was determined by sum of each domain score for all 5 bowel segments and ranged from 0 to 60, higher score indicating more severe disease.

    Measured: Week 12

  2. Number of Participants With Laboratory Test Abnormalities During OLE Period

    Pre-specified criteria for lab abnormalities included- hematology: hemoglobin(Hb), erythrocytes (ery),hematocrit:<0.8*lower limit of normal(LLN);reticulocytes: <0.5*LLN, >1.5*upper limit of normal(ULN); ery mean corpuscular(EMC) volume: <0.9*ULN, >1.11*ULN;EMC Hb: <0.9*LLN; platelets:>1.75*ULN; leukocytes(10^9/L): <0.6*LLN,>1.5*ULN;lymphocyte,neutrophil(10^9/L):<0.8*LLN,>1.2*ULN;basophil,eosinophil,monocyte(10^9/L):>1.2*ULN;activated partial thromboplastin time (sec): >1.1*ULN. Chemistry: bilirubin(mg/dL),aspartate aminotransferase(AT),alanine AT(units per litre)>3.0*ULN; protein, albumin(g/dL):<0.8*LLN; creatinine, triglycerides (mg/dL):>1.3*ULN; urate(mg/dL):>1.2*ULN, potassium (mEq/L):<0.9*LLN; calcium (mg/dL): <0.9*LLN,>1.1*ULN. Urinalysis: pH>8;urine,glucose,protein(mg/dl); ketones, nitrite, urine Hb(scalar):>=1. Number of participants with any lab abnormality meeting pre-specified criteria are reported.

    Measured: From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)

  3. Number of Participants According to Categorization of Vital Signs During OLE Period

    Vital signs including blood pressure (diastolic blood pressure [DBP], systolic blood pressure [SBP], and pulse rate [PR]) were measured in a supine position using automated devices. DBP included value < 50 (millimeter of mercury [mmHg]), change >=20 (mmHg) increase and change >=20 (mmHg) decrease; SBP: value < 90 (mmHg), change >= 30 (mmHg) increase and change >= 30 (mmHg) decrease; PR: value > 120 (beats per minute [bpm]).

    Measured: From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)

  4. Number of Participants With Abnormal Clinically Significant Electrocardiogram Findings During OLE Period

    Single twelve lead ECGs were obtained using an automated ECG machine after participant had rested quietly for at least 10 minutes in a supine position. QTc prolongations were defined as a QTc >=480 milli second (msec) or an absolute change in QTc greater than (>) 60 msec. Clinically significant ECG findings were determined by the investigator.

    Measured: From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)

  5. Number of Participants With Treatment Emergent Adverse Events (TEAEs) During OLE Period

    An adverse event (AE) was any untoward medical occurrence in a study participant administered a study intervention; the event need not necessarily have a causal relationship with the treatment or usage. An AE was considered TEAE to a given treatment if the event started during the effective duration of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period.

    Measured: From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)

  6. Number of Participants With Treatment Emergent Serious Adverse Events (TESAE) During OLE Period

    A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions) or resulted in congenital anomaly/birth defect or was considered an important medical event. An SAE was considered as TESAE if the event started during the effective duration of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period.

    Measured: From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)

  7. Number of Participants With Discontinuations Due to Adverse Events During OLE Period

    An AE was any untoward medical occurrence in a study participant administered a study intervention; the event need not necessarily have a causal relationship with the treatment or usage. Discontinuations from study due to TEAEs were defined as participants with an AE record indicating the AE caused permanent discontinuation from the study but action taken with study treatment was not drug withdrawn. Permanent discontinuations from any study intervention due to TEAEs were defined as participants with an AE record indicating that action taken with study treatment was drug withdrawn. In this outcome measure number of participants with discontinuation from study due to AEs and permanent discontinuation from study intervention due to AEs are reported.

    Measured: From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)

Secondary outcomes (14)

  1. Number of Participants With Laboratory Test Abnormalities During Induction Period

    Pre-specified criteria for lab abnormalities included- hematology: hemoglobin, erythrocytes, hematocrit:<0.8*LLN; reticulocytes: <0.5*LLN, >1.5*ULN; EMC volume: <0.9*ULN, >1.11*ULN;EMC Hb: <0.9*LLN; platelets:>1.75*ULN; leukocytes(10^9/L): <0.6*LLN, >1.5*ULN; lymphocyte, neutrophil(10^9/L):<0.8*LLN, >1.2*ULN; basophil, eosinophil, monocyte(10^9/L):>1.2*ULN; activated partial thromboplastin time (sec): >1.1*ULN. Chemistry: bilirubin(mg/dL),aspartate aminotransferase(AT),alanine AT(units per litre)>3.0*ULN; protein, albumin(g/dL):<0.8*LLN; creatinine, triglycerides (mg/dL):>1.3*ULN; urate(mg/dL):>1.2*ULN, potassium (mEq/L):<0.9*LLN; calcium (mg/dL): <0.9*LLN,>1.1*ULN. Urinalysis: pH>8; urine, glucose, protein(mg/dl); ketones, nitrite, urine Hb(scalar):>=1. Number of participants with any lab abnormality meeting pre-specified criteria are reported.

    Measured: From start of study intervention on Day 1 up to Week 12

  2. Number of Participants According to Categorization of Vital Signs During Induction Period

    Vital signs including blood pressure (diastolic blood pressure [DBP], systolic blood pressure [SBP], and pulse rate [PR]) were measured in a supine position using automated devices. DBP included value < 50 (mmHg), change >=20 (mmHg) increase and change >=20 (mmHg) decrease; SBP: value < 90 (mmHg), change >= 30 (mmHg) increase and PR: value > 120 (bpm).

    Measured: From start of study intervention on Day 1 up to Week 12

  3. Number of Participants With Abnormal Clinically Significant Electrocardiogram Findings During Induction Period

    Single twelve lead ECGs were obtained using an automated ECG machine after participant had rested quietly for at least 10 minutes in a supine position. QTc prolongations were defined as a QTc greater than or equal to (>=)480 milli second (msec) or an absolute change in QTc greater than (>)60 msec. Clinically significant ECG findings were determined by the investigator.

    Measured: From start of study intervention on Day 1 up to Week 12

  4. Number of Participants With Treatment Emergent Adverse Events (TEAEs) During Induction Period

    An AE was any untoward medical occurrence in a study participant administered a study intervention; the event need not necessarily have a causal relationship with the treatment or usage. An AE was considered TEAE to a given treatment if the event started during the effective duration of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period.

    Measured: From start of study intervention on Day 1 up to Week 12

  5. Number of Participants With Treatment Emergent Serious Adverse Events (TESAE) During Induction Period

    A SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions) or resulted in congenital anomaly/birth defect or was considered an important medical event. An SAE was considered as TESAE if the event started during the effective duration of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period.

    Measured: From start of study intervention on Day 1 up to Week 12

  6. Number of Participants Discontinuation Due to Adverse Events During Induction Period

    An AE was any untoward medical occurrence in a study participant administered a study intervention; the event need not necessarily have a causal relationship with the treatment or usage. Discontinuations from study due to TEAEs were defined as participants with an AE record indicating the AE caused permanent discontinuation from the study but action taken with study treatment was not drug withdrawn. Permanent discontinuations from any study intervention due to TEAEs were defined as participants with an AE record indicating that action taken with study treatment was drug withdrawn. In this outcome measure number of participants with discontinuation from study due to AEs and permanent discontinuation from study intervention due to AEs are reported.

    Measured: From start of study intervention on Day 1 up to Week 12

  7. Number of Participants With Serious Infections During Induction Period

    Participants were monitored for development of any infection (viral, bacterial and fungal). Serious infections were treated infections that required parenteral antimicrobial therapy and were present with positive pre-treatment culture and required hospitalization for treatment/met other criteria that required the infection to be classified as SAE. An SAE was any untoward medical occurrence at any dose that: resulted in death; is life-threatening; requires inpatient hospitalization/prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity/results in congenital anomaly/birth defect. Treated infections were infections that required antimicrobial therapy by any route of administration/required any surgical intervention (e.g., incision and drainage).

    Measured: From start of study intervention on Day 1 up to Week 12

  8. Percentage of Participants Who Achieved Clinically Meaningful Endoscopic Improvement (CMEI) (Reduction of >=3 Points From Baseline in SES-CD Score) at Week 12: Induction Period

    CMEI was defined as reduction of >=3 points from baseline in SES-CD score as assessed by centrally read SES-CD score. Baseline: last measurement prior to first dosing on Day1. Following bowel segments were used for calculating SES-CD scores: Ileum, right C, transverse C, left C and rectum. Each segment assessed for 4 domains: presence of ulcers, ulcerated surface, affected surface and presence of narrowing, each scored on scale of 0-3, higher scores indicated more severe condition. Presence of ulcers score: 0=none,1=small ulcer: (0.1-0.5cm),2=Large ulcer(0.5-2cm),3=very large ulcer(>2cm); ulcerated surface score: 0=none,1=<10%,2=10-30% and 3=>30%; affected surface score: 0=unaffected segment, 1=<50%, 2=50-75% and 3=>75%; presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed and 3=cannot be passed. Total SES CD score was determined by sum of each domain score for all 5 bowel segments and ranged from 0 to 60, higher score indicating more severe disease.

    Measured: Week 12

  9. Mean Change From Baseline in SES-CD Score at Week 12: Induction Period

    Mean change from baseline in SES-CD score at Week 12 analyzed using analysis of covariance(ANCOVA)model with treatment,baseline disease activity/extent as factors, baseline SES CD score as covariate. Baseline=last measurement prior to first dosing on Day 1. Following bowel segments used for calculating SES-CD scores: Ileum,right C,transverse C,left C,rectum. Each segment assessed for four domains:presence of ulcers, ulcerated surface, affected surface,presence of narrowing, each score on a scale of 0-3,higher scores=more severe condition. Presence of ulcers score:0=none,1=small ulcer:(0.1-0.5cm),2=large ulcer(0.5-2cm),3=very large ulcer(>2 cm);ulcerated surface score:0=none,1=<10%,2=10-30%,3=>30%;affected surface score:0=unaffected segment,1=<50%, 2=50-75%,3=>75%;presence of narrowing score:0=none,1=single,can be passed,2=multiple can be passed,3=cannot be passed. Total SES CD score=sum of each domain score for all 5 bowel segments,range from 0 to 60,higher score =more severe disease.

    Measured: Baseline and Week 12

  10. Percentage of Participants Achieving >=25% Reduction in SES-CD From Baseline (SES-CD 25) at Week 12: Induction Period

    SES CD25 was defined as >=25% improvement from baseline in SES CD. Baseline was defined as the last measurement prior to first dosing on Day 1. Following bowel segments were used for calculating SES-CD scores: Ileum, right C, transverse C, left C and rectum. Each segment assessed for four domains: presence of ulcers, ulcerated surface, affected surface and presence of narrowing, each scored on a scale of 0 to 3, higher scores indicated more severe condition. Presence of ulcers score: 0=none, 1=small ulcer: (0.1-0.5 centimeter[cm]), 2=Large ulcer(0.5-2 cm), 3=very large ulcer(>2 cm); ulcerated surface score: 0=none, 1=<10%, 2=10-30% and 3=>30%; affected surface score: 0=unaffected segment, 1=<50%, 2=50-75% and 3=>75%; presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed and 3=cannot be passed. Total SES CD score was determined by sum of each domain score for all 5 bowel segments and ranged from 0 to 60, higher score indicating more severe disease.

    Measured: Week 12

  11. Percentage of Participants Achieving Endoscopic Remission (SES-CD Score of <= 2) at Week 12: Induction Period

    Endoscopic remission was defined as SES-CD score of <= 2. Following bowel segments were used for calculating SES-CD scores: Ileum, right colon(C), transverse C, left C and rectum. Each segment assessed for four domains: presence of ulcers, ulcerated surface, affected surface and presence of narrowing, each scored on a scale of 0 to 3, higher scores indicated more severe condition. Presence of ulcers score: 0=none, 1=small ulcer: (0.1-0.5 centimeter[cm]), 2=Large ulcer(0.5-2 cm), 3=very large ulcer(>2 cm); ulcerated surface score: 0=none, 1=<10%, 2=10-30% and 3=>30%; affected surface score: 0=unaffected segment, 1=<50%, 2=50-75% and 3=>75%; presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed and 3=cannot be passed. Total SES CD score was determined by sum of each domain score for all 5 bowel segments and ranged from 0 to 60, higher score indicating more severe disease.

    Measured: Week 12

  12. Percentage of Participants Achieving Mucosal Healing at Week 12: Induction Period

    Mucosal healing was defined as complete absence of ulcers.

    Measured: Week 12

  13. Percentage of Participants Achieving CMEI at Week 64 Among Participants Who Achieved CMEI Response at Week 12 (Baseline of OLE Period): OLE Period

    CMEI was defined as reduction of >=3 points from baseline as assessed by centrally read SES CD score. Baseline: last measurement prior to first dosing on Day 1 of Week 12. Following bowel segments were used for calculating SES-CD scores: Ileum, right C, transverse C, left C and rectum. Each segment assessed for four domains: presence of ulcers, ulcerated surface, affected surface and presence of narrowing, each scored on scale of 0-3, higher scores indicated more severe condition. Presence of ulcers score: 0=none,1=small ulcer: (0.1-0.5 cm),2=Large ulcer(0.5-2 cm),3=very large ulcer(>2 cm); ulcerated surface score: 0=none,1=<10%, 2=10-30% and 3=>30%; affected surface score: 0=unaffected segment, 1=<50%, 2=50-75% and 3=>75%; presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed and 3=cannot be passed. Total SES CD score was determined by sum of each domain score for all 5 bowel segments and ranged from 0-60, higher score indicating more severe disease.

    Measured: Week 64 (Week 52 of OLE period)

  14. Percentage of Participants Achieving SES CD 25 and SES CD 50 at Week 64 Among Participants Who Achieved SES CD 25 and SES CD 50 at Week 12 (Baseline of OLE Period): OLE Period

    SES CD50 and SES CD25: 50% and 25% improvement from baseline, respectively. Baseline: last measurement prior to first dosing on Day 1 of Week 12. Following bowel segments were used for calculating SES-CD scores: Ileum, right C, transverse C, left C and rectum. Each segment assessed for four domains: presence of ulcers, ulcerated surface, affected surface and presence of narrowing, each scored on a scale of 0 to 3, higher scores indicated more severe condition. Presence of ulcers score: 0=none, 1=small ulcer: (0.1-0.5 cm), 2=Large ulcer(0.5-2 cm), 3=very large ulcer(>2 cm); ulcerated surface score: 0=none, 1=<10%, 2=10-30% and 3=>30%; affected surface score: 0=unaffected segment, 1=<50%, 2=50-75% and 3=>75%; presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed and 3=cannot be passed. Total SES CD score was determined by sum of each domain score for all 5 bowel segments and ranged from 0 to 60, higher score indicating more severe disease.

    Measured: Week 64 (Week 52 of OLE period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2018
  2. Study start2 Feb 2018
  3. Primary completion19 Oct 2023
  4. Study completion19 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03395184
Sponsor's protocol ID
B7981007
Other IDs
2017-003359-43, PIZZICATO, 2017
Status last verified
Oct 2024
First submitted
5 Dec 2017
Last updated
30 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Vermeire S, Allegretti JR, Kim HJ, Long MD, Leszczyszyn J, Schreiber S, Kierkus J, Chandler PD, Ramakrishna J, Peeva E, Vincent MS, Shojaee N, Mahling P, Banfield C, Banerjee A, Gale JD, Hung KE. Once-daily oral ritlecitinib or brepocitinib versus placebo in patients with moderate-to-severely active Crohn's disease (PIZZICATO): an international, randomised, phase 2a trial. EClinicalMedicine. 2026 Mar 10;93:103820. doi: 10.1016/j.eclinm.2026.103820. eCollection 2026 Mar.

    PubMed 41852927

  • Fensome A, Ambler CM, Arnold E, Banker ME, Brown MF, Chrencik J, Clark JD, Dowty ME, Efremov IV, Flick A, Gerstenberger BS, Gopalsamy A, Hayward MM, Hegen M, Hollingshead BD, Jussif J, Knafels JD, Limburg DC, Lin D, Lin TH, Pierce BS, Saiah E, Sharma R, Symanowicz PT, Telliez JB, Trujillo JI, Vajdos FF, Vincent F, Wan ZK, Xing L, Yang X, Yang X, Zhang L. Dual Inhibition of TYK2 and JAK1 for the Treatment of Autoimmune Diseases: Discovery of (( S)-2,2-Difluorocyclopropyl)((1 R,5 S)-3-(2-((1-methyl-1 H-pyrazol-4-yl)amino)pyrimidin-4-yl)-3,8-diazabicyclo[3.2.1]octan-8-yl)methanone (PF-06700841). J Med Chem. 2018 Oct 11;61(19):8597-8612. doi: 10.1021/acs.jmedchem.8b00917. Epub 2018 Aug 16.

    PubMed 30113844

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-06651600 and PF-06700841 in people with Crohn's Disease, run by Pfizer at 195 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 195 sites in United States, Poland, Russia, Ukraine, Italy and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction in Simple Endoscopic Score for Crohn's Disease (SES CD50) at Week 12: Induction Period (time frame: Week 12). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03395184, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.

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